Ignite Creation Date:
2025-12-24 @ 2:13 PM
Ignite Modification Date:
2025-12-27 @ 11:57 PM
Study NCT ID:
NCT01660295
Status:
COMPLETED
Last Update Posted:
2012-08-08
First Post:
2011-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C403769', 'term': 'certoparin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'lastUpdateSubmitDate': '2012-08-05', 'studyFirstSubmitDate': '2011-12-20', 'studyFirstSubmitQcDate': '2012-08-05', 'lastUpdatePostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma aXa-Profile: C0', 'timeFrame': '5 days', 'description': 'Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by pre-dose trough (C0,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.'}, {'measure': 'Dose regimen, systemic total exposure to aXa (AUC0-τ,ss)', 'timeFrame': '5 days', 'description': 'Dosage regimen (3,000 o.d., 3,000 b.i.d., 8,000 o.d., 8,000 IU aXa in the morning plus 3,000 IU aXa in the evening, or 8,000 b.i.d. IU aXa) that yields a systemic total exposure to aXa (AUC0-τ,ss) in REN-patients similar to that achieved with 8,000 b.i.d. IU aXa in CON-subjects.'}, {'measure': 'Plasma aXa-Profile: Cmax', 'timeFrame': '5 days', 'description': 'Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by maximum (Cmax,ss), aXa comparing REN-patients with matched CON-subjects studied in parallel.'}, {'measure': 'Plasma aXa-Profile: AUC', 'timeFrame': '5 days', 'description': 'Estimate of the effects of renal insufficiency on the systemic exposure to aXa for once daily (τ = 24 h) repeated doses of 3,000 IU aXa as characterized by total (AUC0-τ,ss) aXa comparing REN-patients with matched CON-subjects studied in parallel.'}]}, 'conditionsModule': {'keywords': ['Severe renal insufficiency certoparin', 'Severe renal insufficiency'], 'conditions': ['Renal Insufficiency']}, 'descriptionModule': {'briefSummary': 'This study will assess the pharmacokinetics in subjects with severe renal insufficiency and healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Healthy subjects OR\n* Subjects with severe renal insufficiency\n\nExclusion criteria:\n\n* Hypersensitivity to study medication\n* Genetic abnormality or disease of clotting system\n* Prior major surgery or bleeding\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01660295', 'briefTitle': 'Pharmacokinetics of Certoparin in Subjects With Renal Insufficiency and Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Single Center, Parallel-group Study to Compare the Single- and Repeated-dose Pharmacokinetics of Stepwise Increasing Doses of Subcutaneous Certoparin (3000 IU o.d., 3000 IU b.i.d., 8000 IU o.d., and 8000 IU b.i.d.) in Subjects With Severe Renal Insufficiency and Healthy Subjects', 'orgStudyIdInfo': {'id': 'CMEX839BDE07'}, 'secondaryIdInfos': [{'id': '2011-001930-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Certoparin control', 'description': 'Participants receive Certoparin 3,000 IU during period 1. Participants will receive 8,000 IU during period 2, if qualified as per medical criteria.', 'interventionNames': ['Drug: Certoparin 3,000 IU Once Daily', 'Drug: Certoparin 8,000 IU Twice a Day']}, {'type': 'EXPERIMENTAL', 'label': 'Certoparin Renal', 'description': 'Participants receive dose escalation upon medical criteria qualification at each period:\n\nCertoparin 3,000 IU once a day during period 1. Certoparin 3,000 IU twice a day during period 2. Certoparin 8,000 IU once a day during period 3. Certoparin 8,000 IU in the morning and 3,000 IU in the evening during period 4 OR Certoparin 8,000 IU twice a day during period 4.', 'interventionNames': ['Drug: Certoparin 3,000 IU Once Daily', 'Drug: Certoparin 3,000 IU Twice a Day', 'Drug: Certoparin 8,000 IU Once Daily', 'Drug: Certoparin 8,000 IU Twice a Day']}], 'interventions': [{'name': 'Certoparin 3,000 IU Once Daily', 'type': 'DRUG', 'otherNames': ['Mono-Embolex'], 'description': 'Certoparin 3,000 IU subcutaneous injection once daily', 'armGroupLabels': ['Certoparin Renal', 'Certoparin control']}, {'name': 'Certoparin 3,000 IU Twice a Day', 'type': 'DRUG', 'otherNames': ['Mono-Embolex'], 'description': 'Certoparin 3,000 IU subcutaneous injection twice a day', 'armGroupLabels': ['Certoparin Renal']}, {'name': 'Certoparin 8,000 IU Once Daily', 'type': 'DRUG', 'otherNames': ['Mono-Embolex'], 'description': 'Certoparin 8,000 IU subcutaneous injection once daily', 'armGroupLabels': ['Certoparin Renal']}, {'name': 'Certoparin 8,000 IU Twice a Day', 'type': 'DRUG', 'otherNames': ['Mono-Embolex'], 'description': 'Certoparin 8,000 IU subcutaneous injection twice a day', 'armGroupLabels': ['Certoparin Renal', 'Certoparin control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12', 'city': 'H-8230 Balatonfüred', 'state': 'Ady E. U.', 'country': 'Hungary', 'facility': 'DRC Drug Research Center Ltd., H-8230 Balatonfüred'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}